Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05083351
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studies@masimo.com', 'phone': '(949) 297-7000', 'title': 'Director, Clinical Lab Operations', 'organization': 'Masimo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 to 5 hours', 'eventGroups': [{'id': 'EG000', 'title': 'MightySat', 'description': 'All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).\n\nMightySat: Noninvasive pulse oximeter', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 13, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial line (healing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal ECG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SpO2 Accuracy of the MightySat Pulse Oximeter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MightySat', 'description': 'All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).\n\nMightySat: Noninvasive pulse oximeter'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61.\n\nArms= √(∑(i=1 to n) ((SpO2\\_i-SaO2\\_i )\\^2 ))/n.', 'unitOfMeasure': '% of oxygen saturated hemoglobin', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MightySat', 'description': 'All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).\n\nMightySat: Noninvasive pulse oximeter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Did not meet data inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Study Staff Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MightySat', 'description': 'All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).\n\nMightySat: Noninvasive pulse oximeter'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-28', 'size': 25628641, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-27T16:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'dispFirstSubmitDate': '2022-12-16', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2021-10-07', 'resultsFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2021-10-07', 'dispFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-27', 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2 Accuracy of the MightySat Pulse Oximeter', 'timeFrame': '1-5 hours', 'description': 'The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61.\n\nArms= √(∑(i=1 to n) ((SpO2\\_i-SaO2\\_i )\\^2 ))/n.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Evaluation of the noninvasive oxygen saturation (SpO2) performance of the noninvasive Masimo MightySat against reference arterial blood samples analyzed by a laboratory CO-oximeter reference instrument. The study will include different subgroups to assess the performance across different genders and skin pigmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 18 to 50 years of age.\n* Subject weighs a minimum of 110 lbs.\n* Subject has a hemoglobin value ≥ 11 g/dL.\n* Subject's baseline heart rate is ≥ 45 bpm and ≤ 85 bpm.\n* Subject's CO value is ≤ 2.0% FCOHb.\n* Subject's blood pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test.\n* Subject is able to read and communicate in English and understands the study and the risks involved.\n\nExclusion Criteria:\n\n* Subject is pregnant.\n* Subject has a BMI \\> 35.\n* Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.\n* Subject has open wounds, inflamed tattoos or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation.\\*\n* Subject has known drug or alcohol abuse.\n* Subject uses recreational drugs.\\*\n* Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.\n* Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.\n* Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures.\n* Subject has any chronic bleeding disorder (e.g. hemophilia).\n* Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)).\n* Subject has donated blood within the past 4 weeks.\n* Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.\n* Subject has any symptomatic cardiac dysrhythmia (e.g. atrial fibrillation) and has not received clearance from their physician to participate.\n* Subject has a known neurological and/or psychiatric disorder (e.g. schizophrenia, bipolar disorder, multiple sclerosis, Huntington's disease) that interferes with the subject's level of consciousness.\\*\n* Subject has taken opioid pain medication 24 hours before the study.\n* Subject has any active signs and/or symptoms of infectious disease (e.g. hepatitis, HIV, tuberculosis, flu, malaria, measles, etc.).\\*\n* Subject is taking medications known to treat any type of infectious disease.\n* Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.\n* Subject has had invasive surgery within the past year, including but not limited to major dental surgery, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery.\\*\n* Subject has symptoms of congestion, head cold, or other illnesses.\n* Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.\n* Subject has any cancer or history of cancer (not including skin cancer).\\*\n* Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.\n* Subject is allergic to lidocaine, chlorhexidine, latex, adhesives, or plastic.\n* Subject has a heart condition, insulin-dependent diabetes, or uncontrolled hypertension.\n* Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the past 6 months.\n* Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (working out, riding a bike, riding a skateboard, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.\n* Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff."}, 'identificationModule': {'nctId': 'NCT05083351', 'briefTitle': 'Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation', 'orgStudyIdInfo': {'id': 'CIP-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MightySat', 'description': 'All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).', 'interventionNames': ['Device: MightySat']}], 'interventions': [{'name': 'MightySat', 'type': 'DEVICE', 'description': 'Noninvasive pulse oximeter', 'armGroupLabels': ['MightySat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Masimo Corporation', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}